An Opportunity

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					                    An Unique Opportunity for
                    Ayurvedic Practioners to enhance
                    their Professional Skills



From

Dr. Sanjay Sharma
Manager – Operations & Research (Karnataka)
VCP Cancer Research Foundation (SIROs)
Evidence Based Therapeutic Ayurveda


    For the first time in the history of Ayurveda, an
     unique opportunity is offered for the BAMS,
     MD/MS graduates to be a part of the
     structured, protocol based Ayurvedic
     Management and documentation of in
     accordance with WHO specified GCP, GLP,
     GMP guidelines
VCPCRF
“To Bring in Stated Efficacy of
Ayurveda into Mainstream Medicine ”
   VCPCRF (SIROs) a leading NGO, in Ayurvedic Research was founded in 1988 to
    carry out in-depth and intensive research to bring the stated efficacy of Ayurveda
    in main stream of medicine by using tools of modern medicine.

   Vaidya Chandra Prakash Cancer Research Foundation (SIROs),is recognized as
    Scientific Industrial Research Organization, by Ministry of Science and
    Technology, Government of India.

   It is a pioneer in developing treatment protocols for certain forms of cancer and
    chronic diseases by using Ras Oushadis (herbo mineral compounds). It has
    obtained US and European patent for its first invention by developing a treatment
    for acute promyelocytic leukamia - a type of blood cancer.
VCPCRF - Achievements

     Developed Metal Based Ayurvedic Formulation & Treatment
      Protocol for the Management of Acute Promyelocytic Leukemia
               Ref: Monograph CCRAS, 2006;
               US of A, European and Indian Patent has been obtained
               Accorded Membership of Indian Cooperative Oncology Network

     Non Iron, Ayurvedic formulation for the treatment of Nutritional
      Anemia
               Ref: Indian Journal of Hematology and Transfusion, Medicine 2000, Vol:18,
                 No.4, Page 79 – 83


     Developed PRAK- 20, an herbo-mineral compound, with
      hepatoprotective, antifibrotic, antiinflamatory, detoxifying and anti
      viral properties, proven by using various experimental and clinical
      research methodology
                     Data on file
VCPCRF - Achievements

  Developed Protocol Based Statistically Significant Clinical Data in the
  Management of the following Diseases

     Certain forms of Cancer              Habitual Abortions
     Childhood Asthma                     Hyperlipidemia
     Chronic Bronchitis                   Infertility
     Chronic Fatigue Syndrome             IBS/Colitis
     Chronic Pancreatitis                 Liver Diseases
     Chronic Osteomylitis                 Migraine
     Depression/Anxiety/Insomnia          Multiple Sclerosis
     Epistaxis                            Nasal Disorders
     Gastritis                            Rheumatoid Arthritis/Gout
     Peptic Ulcers                        Urticaria
Migraine without Aura
(Hereinafter Migraine = Migraine without Aura)




            Most common disabling headache
            19th amongst the debility causing diseases
             worldwide as per WHO
            Prevalence in India is 15 – 20%     (ICMR)



            Greatest Challenge to the Modern Medicine
             till date
Ref: Stephen Dsilberstein, M Alan Stiles, William B Young,
Atlas of Migraine, and Other Head Aches 2nd Edition
Evidence Based Therapeutic Ayurveda

Integrated Approach in the Treatment of Migraine




      Protocols developed by VCPCRF in accordance with GCP
       specified by WHO and IHS
      Integrated approach by way of adopting the definition of the
       disease as per IHS, with defined selection criteria and Ayurvedic
       treatment modalities
      Strict adherence to Informed Consent, Registration and Periodic
       Follow up
      Outcome Based on statistical analysis and documentation
Symptoms

 Migraine is one of the varieties of recurrent headaches and most common types, characterized by the following
     symptoms

 A    Idiopathic, recurrent headache (=> 5 attacks)
 B    4-72 hours duration *
 C    Pain characteristics (2/4)
               Unilateral location
               Pulsating quality
               Moderate to severe intensity **
               Aggravation by routine physical activity
 D. During attack (1/2)
               Nausea and / or Vomiting
               Photophobia and phonophobia
 E. At least one of the following
               1. No secondary cause for headache
               2. Secondary cause suggested but ruled out by investigations
               3. Secondary cause present but migraine does not occur for the first time in close temporal relation to
      the disorder
 F. Transformed Migraine
               Chronic Migraine
               4 hours /day for > 15 days /month
               Evolution from episodic migraine to frequent migraine
                Medication overuse

 *children, sleep; ** untreated or unsuccessfully treated
Symptoms Accompanying Severe Migraine Attacks




                             Nausea                                   87%
                             Photophobia                              82%
                             Light headedness                         72%
                             Scalp tenderness                         65%
                             Vomiting                                 56%
                             Visual disturbances                      36%
                             Paresthesia                              33%
                             Vertigo                                  33%
                             Altered consciousness                    18%

                             (Data Collected on 500patients by International
                             Headache Society)
Causes of Migraine

     No Known etio-patho-physiology of migraine
     Certain theories have been put forward
          Genetic basis of migraine
          Vascular theory of migraine
          Neuronal theory of migraine
          5-HT in migraine
          Dopamine in migraine
          Sympathetic nervous system in migraine

     No Specific Laboratory Investigation for the Diagnosis of Migraine
     Aggravating Factors: Sustained exertion, traveling, red wine,
      cheese, chocolates, hunger, lack of sleep, menses, odors,
      diarrhea
     Relieving Factors: Sleep, exhilaration, Pain killers, Pregnancy
Current Treatment

  The recurring attacks of migraine may be
    reduced by
   Stress Reduction
   Elimination of certain food form diet
     Regular Exercise


  Temporary Relief is Obtained by
   Cold Packs
   Pressure on the bulging arteries
   Analgesics/Migraine Specific Drugs
Current Treatment in Conventional Medicine



  ß-blockers, anticonvulsants, tricyclic
   antidepressent, calcium channel blocker,
   riboflavin, magnesium
 Selective 5-HT 1B/1D receptor agonists
  Long-term administration of these drugs have
   adverse effects; usage should be minimal,
   and under close medical supervision.
Protocol Based Ayurvedic Treatment for Migraine



    Ayurvedic treatment protocol comprising diet,
     life-style and medicines
    Retrospective and Prospective clinical data
     from the year 1985 to 2006
    Improves working efficiency
    Significant reduction in paying visit to
     emergency and pain killers
    Saves from possible side effects & MIH
Study at VCPCRF

    Preliminary Studies (1985 – 2002) by VBP

    I Prospective Study
            Conducted at Sri Dhanvantry Ayurvedic College & Hospital between
             June 2002 & December 2004 by VBP & VPM


    II Prospective Study (Ongoing)
            Started on 15th May 2005, in different locations across Karnataka
             Evaluated on completion of 1 year (Ref: First Annual Report) by VRB,
             VHM, VSK, VHE, VSA, VSH
First Prospective Study – CHD (n= 131/104)
II Prospective Study
at various locations in Karnataka (n=267/101)


      Aims and Objectives:

       To prospectively study the impact of Ayurvedic
       treatment in the prevention of common
       migraine attacks, and its impact on migraine
       frequency, intensity and associated symptoms
       using Migraine disability assessment scale
       [MIDAS] and visual analogue scale [VAS].
Material and Methods



      From 15 May 2005 to 31 March 2006 a total
      of 267 patients were enrolled in 7 Ayurvedic
      clinics in the state of Karnataka** ( 3 each in
      Bangalore & Bellary and 1 in Tumkur district)
      under using centralized Postcard registry
      system under VCPC Research Foundation
      (SIROs), Dehradun, Uttranchal, India.
Inclusion and Exclusion Criteria


       The selection criteria included patients with
       normal blood bio-chemistry and
       hematological parameters.
       All patients’ fulfilled International Headache
       Society [IHS] 1998 criteria for Migraine.
       Patients with deranged hematological
       blood biochemistry were excluded from the
       study. The patients characteristics are as
       shown
Treatment Protocol

      The given treatment was derived following Ayurvedic concept
      of diagnosing of Shiroruja

      All medications were prepared at Bharat Bhaishajaya Shala
      Private Ltd, Dehradun and given to all the patients in daily
      dosages (table 2) for a period of at least 10 days to a maximum
      period of more than 180 days (table3).

       Lifestyle changes like three meals three snacks providing
      adequate calories and meals devoid of nicotine, caffeine,
      reheated food, aerated drugs and minimum of eight hours of
      sleep were recommended.
Response Evaluation



 All Patients were evaluated for Intention to
  treat analysis and severity of pain and
  frequency of migraine attacks on day 0,
  30, 60 and 90 of treatment.
 However, MIDAS score was done for
  patients who have completed treatment for
  at least 90 days
II Prospective Study - Karnataka
(n= 267/101)

                                      142                                                       History of Migraine
       Distribution
                                                                                25              23


                                                                                20




                                                                       Number
                                                                                15                           13
                              57                                                                      12          12

                                                                                10
                                                  27                                                                     5
                                            22                                   5
                 12                                                                   2
                                                                                                                               1
                                                                                                                                                 2
       1     2        4                                                          0
                                                                                                                                     0     0

                                                                                     <1   1-5   5-10 10-15 15-20 20-25 25-30 30-35 35-40 40-45 45-50
       <11       11<18         18<45        >45
                                                                                                           Duration (years)
                      Male   Female


                                                   Frequency of Attacks Day – 0
                                                           Occ, 13
                                            2m/1, 3                    C, 55

                                             m/1, 15
                                            m/2, 43

                                                                                     w/4, 46
                                             m/3, 8
                                             0 Day                         w/3, 4
                                                                     w/2, 13
                                                        w/1, 67


                                                                                                                             n=267
Impact of AyT on MIDAS
(Migraine Disability Assessment Scale)



   Duration         Mean Midas             p Value         Day         0            90
                       Score                               Gr I        0            24
                                                           Gr II       2            24

         Day 0        60.5  40.6                -         Gr III      9            19
                                                           Gr IV       90           34
        Day 90       19.22  18.41        .00000267        Mean        60.45        19.20



                      Day 0
                                                                    60.45    60.45




                                                               Impact = 62.2% Reduction
                    Day 90               19.21        19.21



                                    0                20       40           60             80

                                                     M ean M idas Score
                                                        Mean MIDAS Score
Impact of AyT on VAS                                                  (Visual Analog Scale)



                       Day      Day        Day
            Day 0                                      Duration          Mean           p Value
                       30        60         90
                                                                       VAS Score
 Mild         0        12       43           80         0 Day
                                                                       9.00 ± 1.42         -
 Moderate     9        48       43           18         30 days
                                                                       6.11 ± 2.21      0.00086
 Severe      23        30       14           3                                                      -4
                                                        60 days                      0.00321 x 10
                                                                       4.05 ± 2.23
 Very
                                                                                                    -8
 Severe      69        11        1           0          90 days        1.41 ± 2.32   0.00119 x 10


                     Reduction in Mean Pain Score
                    (n=101)               (p<0.05)
                  10
                   9         9.01
                   8
                   7
                   6                   6
                                                                         Mean Pain
                   5
                                                                         Score
                   4                              3.9
                   3
                   2                                            2.3
                   1
                   0
                        Day 0       Day 30    Day 60     Day 90
Impact on Associated Symptoms



                          260 Nausea   Photophobia Phonophobia
                          240
                                  Vomiting
                          220
                          200
                          180
        No. of Patients




                          160
                          140                                           Fatigue
                          120                            Blurred
                          100                            Vision  Sweats
                                                                                Abdominal
                           80
                                                                                Pain
                           60
                           40
                           20
                            0

                                  0 Day       30 Days       60 Days      90 Days
 Impact of AyT on Associated Symptoms


  Symptom                             Day 0        Day 30          Day 60           Day 90
   Nausea        No of Patients (%)   93 (92.1)    50 (49.5)        17(16.8)         06(05.9)
                 p Value                          *2.86 x 10-11   *6.79 x 10 -27   *1.78 x 10-34
  Vomiting       No of Patients (%)   84 (83.2)    44 (43.6)       17 (16.8)        09 (08.9)
                 p Value                          *5.17 x 10-9    *4.17 x 10 -21   *3.41 x 10-26
Photophobia      No of Patients (%)   89 (88.1)    50 (49.5)       15 (14.8)        07 (06.9)
                 p Value                          *3.15 x 10-9    *2.05 x 10 -25   *7.11 x 10-31
Phonophobia      No of Patients (%)   88 (87.1)    45 (44.6)        12 (11.9)       05 (04.9)
                 p Value                          *1.77 x 10-10   *1.07 x 10 -26   *1.04 x 10-31
Blurred Vision   No of Patients (%)   29 (28.7)     11(10.9)       03 (03.0)         01(01.0)
                 p Value                           *0.00023       *1.19 x 10 -8    *1.19 x 10 -8
   Fatigue       No of Patients (%)   46 (45.5)    24 (23.8)       08 (07.9)        02 (02.0)
                 p Value                            *0.0014       *1.53 x 10 -9    *3.50 x 10-13
 Abdominal       No of Patients (%)   29 (28.7)    07 (06.9)       02 (02.0)           0 (0)
   pain          p Value                          *5.24 x 10-7    *1.36 x 10 -7    *5.92 x 10 -9
VCPCRF Criteria for Assessment
Conclusion

  Ayurvedic Treatment for Migraine without
   aura, has been highly significant
   statistically and clinically, in prevention of
   Migraine attacks
  Scientific Accreditation in International
   Community
   Poster Presented
   and discussed at
  16th Migraine Trust
      International
      Symposium,
18 - 20 September 2006
The Conference Centre,
Kensington Town Hall,
       London, UK
What are we looking for?


     Your Partnership in promotion of Evidence
      Based Therapeutic Ayurveda (EBTA), in the
      treatment of Migraine as a team member of
      VCPCRF

     Your association in having Ayurveda as the
      Mainstream Medicine acceptable world wide
Your Benefits


     Research Team Member of VCPCRF
     Personalized Training and Certification
     Membership in the body of EBTA practioners
     Social & Professional Recognition
     Exposure to International Research
      Community
     Opportunity to expand in specialized treatment
      in various other treatments in future
     Financial Gains
Our Strengths




    Training



                Protocol



                           Product
We Provide

    Training & Certification in EBAT – Integrated Approach
     for Migraine Treatment
    All required materials including CRF’s, Manuals,
     Visual CD’s
    Medicines
    Ongoing Support over email and phone on Patient
     Care & Documentation
    CME’s
Next Step

    Enroll for the Training & Certification
    Enhance your skills & be a specialist
    Adopt Protocol Based Treatment for Migraine
     for your existing and new patients
    Organize and Participate in the events for
     creating awareness amongst the masses
     about Ayurvedic Treatment for Migraine
    Participate in CME’s and Other Events
Contact
 Dr. Sanjay Sharma
 Manager – Operations & Research
 VCPCRF (SIRO’s), Dehradoon




 Ph: +91 9845057782
thank you


            Looking forward for a
              mutually beneficial
                      association